Registered outcomes12

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

1 to 12 of 12

List	Outcome	Time frame	Description
Primary	Change From Baseline in Weekly Spontaneous Bowel Movement (SBM) Frequency Over the 4 Week Treatment Period Compared to Placebo and Across Treatment Groups	Baseline to Week 4	Weekly SBM rate computed for each week
Secondary	Change From Baseline in Frequency of Abdominal Pain and Abdominal Discomfort Over the 4-week Treatment Period Compared to Placebo and Across Treatment Groups..	Baseline to Week 4	Weekly frequency was calculated as the number of abdominal pain episodes and abdominal discomfort episodes per week, based on daily diary entries. Baseline was the average weekly frequency during the 2-week baseline assessment period. Values shown are mean change from baseline (SD).
Secondary	Change From Baseline in Severity of Abdominal Pain and Abdominal Discomfort Over the 4-week Treatment Period Compared to Placebo and Across Treatment Groups..	Baseline to Week 4	Severity of abdominal pain and abdominal discomfort was recorded daily using an electronic diary on a 0-10 numeric rating scale (0 = no pain/discomfort; 10 = worst possible). Weekly averages were calculated; baseline was the average score during the 2-week baseline period. Values shown are mean change from baseline.
Secondary	Change From Baseline in Frequency of Complete Spontaneous Bowel Movements (CSBM)	Baseline to Week 6	Weekly frequency of complete spontaneous bowel movements (CSBMs) was calculated based on daily diary entries. Baseline was the average weekly frequency during the 2-week baseline period. Values shown are mean change from baseline (SD) at end of 4 weeks of study.
Secondary	Change From Baseline in Frequency of Bowel Movements (BM)	Baseline to Week 4	Weekly frequency of bowel movements (BMs) was calculated based on daily diary entries. Baseline was the average weekly frequency during the 2-week baseline period. Values shown are mean change from baseline (SD).
Secondary	Time to First Bowl Movement (in Days)	Day 1 to first BM during Treatment Period	This outcome was analyzed as a time-to-event variable (time to first complete spontaneous bowel movement), and confidence intervals were estimated using Kaplan-Meier methods.
Secondary	Change From Baseline in Stool Consistency (Based on Bristol Stool Form Scale, BSFS or Modified Bristol Stool Form Scale for Children, mBSFS-C)	Baseline to Week 4	Weekly stool consistency scores based on BSFS (≥12 years) or mBSFS-C (6-11 years). BSFS Scale is a 7 point scale, from Type 1 (Hard to pass) to Type 7 (entirely liquid). mBSFS-C is a 5 point scale, from Type 1 (hard to pass) to Type 5 (watery, no solid pieces).
Secondary	Use of Rescue Medication	Baseline to Week 4	Number of rescue medication tablets (Dulcolax® 5 mg) used during the 4-week treatment period. Subjects were instructed to use rescue medication only if ≥72 hours had passed since last bowel movement.
Secondary	Change From Baseline in Frequency of Fecal Incontinence	Baseline to Week 4	Weekly fecal incontinence episodes recorded in daily diary.
Secondary	Change From Baseline in Severity of Defecation Pain	Baseline to Week 4	Severity of abdominal pain scored daily on a 0-10 numeric rating scale (0 = no pain, 10 = worst possible pain). Weekly averages were calculated from daily scores.
Secondary	Change From Baseline in Frequency of Pain With Defecation	Baseline to Week 4	Pain with defecation was recorded in daily diaries as the number of episodes per week. Results represent the mean change from baseline in weekly frequency.
Secondary	Change From Baseline in Frequency of Large Diameter Stools	Baseline to Week 4	Weekly frequency of large diameter stools recorded in daily diary.

Source ClinicalTrials.govtrials-2026-11-12-0.5.0

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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